评估沃克帕唑在巴基斯坦人群胃肠道疾病中的疗效和安全性的真实世界证据。
Real-World Evidence to Evaluate the Efficacy and Safety of Vonoprazan in Gastrointestinal Disorders in the Pakistani Population.
作者信息
Abbasi Amanullah, Siddiqui Shajee Ahmad, Ram Bikha, Khan Jibran Umar Ayub, Sheikh Khalid, Ali Asif, Raja Memon Waseem, Rehan Muhammad, Zia Ul Haq Muhammad, Kumar Seetlani Naresh, Akhter Tayyab S, Khoso Masood, Javed Asif, Hussain Khokhar Riaz, Hussain Memon Zaheer, Akbar Wajid, Naeem M, Shaikh Samiullah, Khan Khattak Abbas, Memon A Qayoom, Bhatty Shaheen, Sultan Omar, Shani Idress, Maheshwary Neeta
机构信息
Internal Medicine, Civil Hospital Karachi, Karachi, PAK.
Internal Medicine, Pakistan Institute of Medical Sciences, Islamabad, PAK.
出版信息
Cureus. 2023 Nov 18;15(11):e48994. doi: 10.7759/cureus.48994. eCollection 2023 Nov.
BACKGROUND AND AIM
While proton pump inhibitor (PPI) therapy has proven to be effective in managing gastroesophageal reflux disease (GERD), a notable portion of patients who experience GERD symptoms may not respond to this treatment. Research suggests that roughly 30% of individuals with a presumed GERD diagnosis may continue to experience symptoms, whether partially or completely, even when receiving PPI therapy. The aim of this study was to assess the treatment of gastrointestinal diseases with a novel potassium-competitive acid blocker (P-CAB), vonoprazan, in terms of its effectiveness and safety in the Pakistani population.
METHODS
This prospective, multicenter, observational study was conducted in Pakistan. This study included 1,642 patients from January 2023 to August 2023, aged 18 years, with gastrointestinal disorders. All demographic data, medical history, GERD severity assessment questionnaire (GerdQ), and laboratory parameters, including stool assessment for Helicobacter pylori (H. pylori), were observed. Patients were orally treated with vonoprazan at doses of 10 mg or 20 mg, once or twice daily. Statistical analysis was done by one-way ANOVA.
RESULTS
Out of 1,642 patients, 840 (51.2%) were males and 802 (48.8%) were females, with a mean age of 39.81±14.61 years. The mean GerdQ score at baseline was 20.37±15.87, 7.24±8.15 at the second week of treatment, and 3.70±6.31 at the fourth week of treatment (p<0.001). 90.74% of patients achieved H. pylori eradication. Most patients were acid regurgitation and heartburn-free for >70% of days. Most of the patients, 1,283 (78.13%), exhibited good treatment compliance. Mild adverse events were reported in 37 (2.3%) patients.
CONCLUSIONS
The use of vonoprazan significantly reduced the likelihood of GERD by improving symptoms and was also highly effective in the elimination of H. pylori infections. Vonoprazan was generally well tolerated.
背景与目的
虽然质子泵抑制剂（PPI）疗法已被证明在治疗胃食管反流病（GERD）方面有效，但相当一部分有GERD症状的患者可能对这种治疗无反应。研究表明，即使接受PPI治疗，大约30%疑似GERD诊断的个体可能仍会部分或完全持续出现症状。本研究的目的是评估新型钾离子竞争性酸阻滞剂（P-CAB）沃克替尼在巴基斯坦人群中治疗胃肠道疾病的有效性和安全性。
方法
本前瞻性、多中心、观察性研究在巴基斯坦进行。本研究纳入了2023年1月至2023年8月期间18岁及以上患有胃肠道疾病的1642名患者。观察了所有人口统计学数据、病史、GERD严重程度评估问卷（GerdQ）以及实验室参数，包括粪便幽门螺杆菌（H. pylori）检测。患者口服10毫克或20毫克剂量的沃克替尼，每日一次或两次。采用单因素方差分析进行统计分析。
结果
1642名患者中，840名（51.2%）为男性，802名（48.8%）为女性，平均年龄为39.81±14.61岁。基线时GerdQ平均评分为20.37±15.87，治疗第二周时为7.24±8.15，治疗第四周时为3.70±6.31（p<0.001）。90.74%的患者实现了幽门螺杆菌根除。大多数患者在超过70%的天数里无反酸和烧心症状。大多数患者，即1283名（78.13%），表现出良好的治疗依从性。37名（2.3%）患者报告了轻度不良事件。
结论
使用沃克替尼通过改善症状显著降低了GERD的可能性，并且在根除幽门螺杆菌感染方面也非常有效。沃克替尼总体耐受性良好。
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